This clinical trial is focused on studying a type of brain cancer called medulloblastoma, which occurs in children. The study aims to explore different treatment approaches for children with various risk levels of this disease. The treatments being tested include a combination of radiation therapy and chemotherapy, which involves using drugs to kill cancer cells. The chemotherapy drugs used in this study are carboplatin, methotrexate, cisplatin, cyclophosphamide, doxorubicin hydrochloride, vinblastine sulfate, vincristine, and lomustine. These drugs are administered in different forms, such as solutions for infusion or injection, and capsules.
The purpose of the study is to determine the effectiveness of these treatments in improving the survival rates of children with medulloblastoma. The study is divided into different groups based on the risk level and biological characteristics of the cancer. For example, one group will receive a combination of radiation and chemotherapy, while another group will receive chemotherapy alone. The study will also look at the impact of these treatments on the quality of life and any side effects experienced by the participants.
Participants in the study will receive treatment over a period of time, with regular follow-ups to monitor their progress. The study will assess the event-free survival, which means the length of time the participants remain free from cancer-related events, such as recurrence or progression of the disease. The study will also evaluate overall survival, which is the length of time the participants live after starting the treatment. By comparing the outcomes of different treatment approaches, the study aims to find the most effective way to treat medulloblastoma in children.
1joining the study
Upon joining the study, the patient will be assigned to one of the treatment arms based on their specific medulloblastoma profile. This assignment is determined by the biological characteristics of the tumor and other factors.
2initial treatment phase
The initial treatment phase involves radiation therapy. Depending on the assigned treatment arm, the patient will receive a specific dose of radiation aimed at the neuraxis and the primary tumor site. The dose varies between 18.0 Gy and 23.4 Gy, with additional boosts as required.
3chemotherapy administration
Following radiation therapy, the patient will undergo chemotherapy. The specific drugs and their administration routes include:
Carboplatin – administered intravenously.
Methotrexate – administered both intravenously and intraventricularly.
Cisplatin – administered intravenously.
Cyclophosphamide – administered via intravenous infusion.
After the initial chemotherapy, the patient will enter a maintenance phase. This phase involves continued chemotherapy at a reduced intensity to help prevent the recurrence of the tumor.
5monitoring and follow-up
Throughout the trial, the patient’s health and response to treatment will be closely monitored. This includes regular assessments of event-free survival, overall survival, and progression-free survival.
Additional evaluations will focus on the patient’s quality of life, hearing, endocrine function, and neurological function.
6end of trial
The trial is expected to conclude by December 31, 2027. At this point, the final data will be collected and analyzed to determine the effectiveness and safety of the treatments.
Who Can Join the Study?
Age at diagnosis should be at least 3 to 5 years old (depending on the country) and less than 16 years for some groups, and less than 22 years for others.
Must have a type of brain tumor called medulloblastoma, confirmed by tests.
For certain groups, the tumor must not have specific genetic changes, like changes in genes called TP53, PTCH, SUFU, BRCA2, and PALB2.
Must not have received any treatment for medulloblastoma before, except for surgery.
Must not have significant hearing problems, as checked by hearing tests.
Post-surgery treatment should start within 28 days, and no later than 40 days after surgery.
Must have normal liver, kidney, and blood function, as determined by specific medical tests.
Must not have any other medical conditions that would prevent following the study treatment plan.
Must provide high-quality samples of the tumor and blood for research purposes.
Must have written consent from the patient or guardian to participate in the study, including agreement to biological studies.
Approval from national and local ethical committees is required for participation.
Who Cannot Join the Study?
Patients who have a different type of cancer other than medulloblastoma cannot participate. Medulloblastoma is a type of brain tumor.
Patients who are not within the specified age range for the study cannot participate. The study is for children and adolescents.
Patients who are not considered to have a standard-risk or high-risk biological profile for medulloblastoma cannot participate. This refers to specific characteristics of the tumor.
Patients who have a genetic mutation known as TP53 mutation that is not part of the study’s focus cannot participate. A TP53 mutation is a change in a gene that can affect how cells grow.
Patients who are unable to undergo the required treatments, such as radiation or chemotherapy, cannot participate. These are standard cancer treatments.
Patients who are not able to follow the study procedures or attend regular follow-up visits cannot participate.
Patients who are pregnant or breastfeeding cannot participate, as the treatments may affect the baby.
Patients who have other serious health conditions that could interfere with the study treatments cannot participate.
Carboplatin is a chemotherapy medication used in the trial to see if it improves the survival of children with standard-risk medulloblastoma when given alongside radiotherapy. It is being tested to determine if it can help prevent the cancer from returning or worsening.
Neuraxis Irradiation is a type of radiotherapy used in the trial. It involves directing radiation to the central nervous system, which includes the brain and spinal cord, to treat medulloblastoma. The goal is to eliminate cancer cells and reduce the risk of the cancer spreading or coming back.
Boost to the Primary Tumour refers to an additional dose of radiation given specifically to the main tumor site. This is done to ensure that the primary tumor receives a higher concentration of radiation, which may help in more effectively controlling or eliminating the tumor.
Reduced-Intensity Chemotherapy is a treatment approach that uses lower doses of chemotherapy drugs. In this trial, it is used to treat children with a low-risk biological profile of medulloblastoma, aiming to maintain high survival rates while minimizing side effects.
Modified Maintenance Chemotherapy is a tailored chemotherapy regimen used after initial treatment to help keep the cancer from returning. In this trial, it is used for children with an average-risk biological profile of medulloblastoma, with adjustments made to the standard chemotherapy plan to improve outcomes.
Medulloblastoma – Medulloblastoma is a type of brain tumor that primarily affects children and originates in the cerebellum, the part of the brain responsible for coordination and balance. It is considered a fast-growing tumor that can spread to other parts of the brain and spinal cord through the cerebrospinal fluid. The disease often presents with symptoms such as headaches, nausea, vomiting, and problems with balance or coordination. As the tumor progresses, it may lead to increased intracranial pressure and neurological deficits. Medulloblastoma is classified into different subtypes based on genetic and molecular characteristics, which can influence the behavior and progression of the disease. Understanding these subtypes is crucial for determining the most appropriate treatment approach.
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